Durvalumab - PharmaKB

Imfinzi(durvalumab)

Imfinzi (durvalumab) is an antibody pharmaceutical. Durvalumab was first approved as Imfinzi on 2017-05-01. It is used to treat transitional cell carcinoma in the USA. It has been approved in Europe to treat non-small-cell lung carcinoma. The pharmaceutical is active against programmed cell death 1 ligand 1.

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Drug

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Events Timeline

YTD

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

Primary completion date

Completion date

Results first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
neoplasms	D009369
respiratory tract diseases	D012140

Trade Name

FDA

EMA

Imfinzi

Drug Products

FDA

EMA

Reference product - 351(a)

Interchangeable product - 351(k)

Biosimilar product - 351(k)

Durvalumab

Tradename	Proper name	Company	Number	Date	Products
Imfinzi	durvalumab	AstraZeneca	N-761069 RX	2017-05-01	2 products

Labels

FDA

EMA

Brand Name	Status	Last Update
imfinzi	Biologic Licensing Application	2024-08-15

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
transitional cell carcinoma	—	D002295	—

Agency Specific

FDA

EMA

Expiration	Code
durvalumab, Imfinzi, AstraZeneca UK Ltd
2029-10-21	Orphan excl.

Patent Expiration

No data

ATC Codes

L: Antineoplastic and immunomodulating agents

— L01: Antineoplastic agents

— L01F: Monoclonal antibodies and antibody drug conjugates

— L01FF: Pd-1/pdl-1 (programmed cell death protein 1/death ligand 1) inhibitors

— L01FF03: Durvalumab

HCPCS

Code	Description
J9173	Injection, durvalumab, 10 mg

Clinical

Clinical Trials

793 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Non-small-cell lung carcinoma	D002289	—	—	42	114	34	2	21	199
Lung neoplasms	D008175	HP_0100526	C34.90	42	125	29	2	17	198
Neoplasms	D009369	—	C80	57	43	2	2	5	90
Neoplasm metastasis	D009362	EFO_0009708	—	7	8	—	1	—	14
Pneumonia	D011014	EFO_0003106	—	—	1	—	1	1	3
Oncogenes	D009857	—	—	—	—	—	1	1	2
Meningeal carcinomatosis	D055756	EFO_1001012	—	—	—	—	1	—	1

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Carcinoma	D002277	—	C80.0	49	105	19	—	7	159
Small cell lung carcinoma	D055752	—	—	12	41	8	—	7	66
Breast neoplasms	D001943	EFO_0003869	C50	31	41	4	—	1	63
Hepatocellular carcinoma	D006528	—	C22.0	13	37	7	—	9	59
Liver neoplasms	D008113	EFO_1001513	C22.0	15	36	7	—	6	54
Squamous cell carcinoma	D002294	—	—	19	27	4	—	3	45
Squamous cell carcinoma of head and neck	D000077195	—	—	19	27	4	—	1	43
Urinary bladder neoplasms	D001749	—	C67	10	30	5	—	—	39
Biliary tract neoplasms	D001661	—	C24.9	8	24	6	—	3	36
Ovarian neoplasms	D010051	EFO_0003893	C56	16	23	1	—	—	31

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Adenocarcinoma	D000230	—	—	13	37	—	—	—	41
Colorectal neoplasms	D015179	—	—	18	30	—	—	—	38
Pancreatic neoplasms	D010190	EFO_0003860	C25	19	25	—	—	—	35
Cholangiocarcinoma	D018281	—	C22.1	6	25	—	—	—	29
Lymphoma	D008223	—	C85.9	17	13	—	—	—	23
Melanoma	D008545	—	—	11	10	—	—	2	19
Esophageal neoplasms	D004938	—	C15	7	14	—	—	—	16
Stomach neoplasms	D013274	EFO_0003897	C16	7	12	—	—	—	14
Prostatic neoplasms	D011471	—	C61	4	11	—	—	—	13
Small cell carcinoma	D018288	—	—	3	8	—	—	1	9

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Primary myelofibrosis	D055728	—	D47.4	2	—	—	—	—	2
Myeloproliferative disorders	D009196	—	D47.1	1	—	—	—	—	1
Precursor cell lymphoblastic leukemia-lymphoma	D054198	—	—	1	—	—	—	—	1
Bcr-abl positive chronic myelogenous leukemia	D015464	EFO_0000340	—	1	—	—	—	—	1
Myelomonocytic leukemia chronic	D015477	—	C93.1	1	—	—	—	—	1
Anemia	D000740	HP_0001903	D64.9	1	—	—	—	—	1
Hodgkin disease	D006689	—	C81	1	—	—	—	—	1
Leukemia myeloid chronic atypical bcr-abl negative	D054438	—	C92.2	1	—	—	—	—	1
Myelodysplastic-myeloproliferative diseases	D054437	—	—	1	—	—	—	—	1
Myeloid leukemia chronic-phase	D015466	—	—	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Myocarditis	D009205	—	I51.4	—	—	—	—	3	3
Heart diseases	D006331	EFO_0003777	I51.9	—	—	—	—	2	2
Autoimmune diseases	D001327	HP_0002960	M30-M36	—	—	—	—	2	2
Cardiovascular diseases	D002318	HP_0001626	—	—	—	—	—	1	1
Cardiomyopathies	D009202	EFO_0000318	I42	—	—	—	—	1	1
Pericarditis	D010493	EFO_0007427	I30	—	—	—	—	1	1
Vasculitis	D014657	HP_0002633	—	—	—	—	—	1	1
Human influenza	D007251	EFO_0007328	J11.1	—	—	—	—	1	1
Myositis	D009220	EFO_0000783	G72.49	—	—	—	—	1	1
Drug-related side effects and adverse reactions	D064420	—	T88.7	—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Durvalumab
INN	durvalumab
Description	Durvalumab (human mab)
Classification	Antibody
Drug class	monoclonal antibodies
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	>5X8M:B\|durvalumab heavy chain EVQLVESGGGLVQPGGSLRLSCAASGFTFSRYWMSWVRQAPGKGLEWVANIKQDGSEKYYVDSVKGRFTISRDNAKNSLY LQMNSLRAEDTAVYYCAREGGWFGELAFDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTV SWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTHHHHHH >5X8M:C\|durvalumab light chain EIVLTQSPGTLSLSPGERATLSCRASQRVSSSYLAWYQQKPGQAPRLLIYDASSRATGIPDRFSGSGSGTDFTLTISRLE PEDFAVYYCQQYGSLPWTFGQGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNS QESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC